Samsung Electronics has made significant strides in health technology, with its Samsung Health Monitor app receiving De Novo authorization from the U.S. Food and Drug Administration (FDA) for a pioneering sleep apnea feature. This authorization marks a milestone, as the feature is the first of its kind to be approved by the FDA, following its earlier approval by Korea’s Ministry of Food and Drug Safety (MFDS). The sleep apnea detection functionality is designed for use with a compatible Samsung Galaxy Watch and phone, aiming to identify signs of moderate to severe obstructive sleep apnea (OSA) over a two-night monitoring period.

The sleep apnea feature is intended for individuals over the age of 22 who have not been previously diagnosed with sleep apnea. It enables these users to detect signs of the condition by monitoring their sleep on two occasions for more than four hours within a ten-day period. OSA, a common yet often undiagnosed chronic sleep disorder, can lead to significant health risks, including cardiovascular diseases, if left untreated. The National Sleep Foundation estimates that roughly 25% of men and 10% of women in the U.S. suffer from OSA, highlighting the potential impact of Samsung’s new feature.

Samsung’s commitment to improving sleep health extends beyond mere detection. The company emphasizes the importance of understanding sleep patterns, building better habits, and creating a sleep-friendly environment as key components of good sleep health. With the addition of the sleep apnea detection feature, Samsung aims to empower Galaxy Watch users to take proactive steps in monitoring and improving their sleep, thereby enhancing their overall health and well-being.

The feature will be available in the U.S. on the Galaxy Watch series via the Samsung Health Monitor app in the third quarter. It is important to note that the sleep apnea feature is an over-the-counter (OTC) software-only mobile medical application and is not intended to replace traditional diagnostic methods or treatments provided by healthcare professionals.

This FDA authorization represents a significant advancement in wearable health technology, offering users a convenient and non-invasive method to monitor their sleep health and potentially identify serious conditions like OSA. By integrating such features into everyday devices like the Samsung Galaxy Watch, Samsung is at the forefront of leveraging technology to enhance public health.

  Samsung Electronics, Sleep Apnea, US FDA